Selincro

Patient Information Leaflet

Selincro 18 mg film-coated tablets

nalmefene
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet:

1. What Selincro is and what it is used for
2. What you need to know before taking Selincro
3. How to take Selincro
4. Possible side effects
5. How to store Selincro
6. Contents of the pack and other information

1. What Selincro is and what it is used for

Selincro contains the active substance nalmefene.
Selincro is used to reduce alcohol consumption in adult patients with alcohol dependence who continue to have high levels of alcohol consumption 2 weeks after their first visit to the doctor.
Alcohol dependence occurs when a person has a physical or psychological dependence on alcohol intake.
High alcohol consumption is defined as more than 60 g of pure alcohol per day for men and more than 40 g of pure alcohol per day for women. For example, one bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g of alcohol, and one bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g of alcohol.
Your doctor has prescribed Selincro because you have not been able to reduce your alcohol consumption on your own. Your doctor will provide you with motivational support to help you continue your treatment and thereby reduce your alcohol consumption.
Selincro works by acting on brain processes that are responsible for the ongoing urge to drink.
High levels of alcohol consumption are associated with increased health risks and social problems. Selincro can help you reduce the amount of alcohol you drink and help you maintain lower alcohol consumption levels.

2. What you need to know before taking Selincro

Do not take Selincro:

• if you are allergic to nalmefene or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines containing opioids, such as methadone or buprenorphine, or painkillers (such as morphine, oxycodone, or other opioids).
• if you have or have recently had opioid dependence. You may experience acute opioid withdrawal symptoms (such as nausea, vomiting, agitation, sweating, and anxiety).
• if you are suffering from or suspect you may be suffering from opioid withdrawal symptoms.
• if your liver or kidneys do not function properly.
• if you suffer or have recently suffered from certain alcohol withdrawal symptoms (such as seeing, hearing, or sensing things that are not there, seizures, or agitation).

Warnings and precautions
Talk to your doctor or pharmacist before taking Selincro. Inform your doctor if you have any other medical conditions,
for example depression, epilepsy, or liver and kidney diseases.
If you and your doctor have decided that the immediate goal of your treatment is abstinence (stopping alcohol consumption completely), you must not take Selincro, as Selincro is indicated for reducing alcohol consumption.
If you require emergency medical treatment, inform the doctor that you are taking Selincro. Your treatment with Selincro may influence the doctor’s choice of emergency treatment.
If you are scheduled to undergo surgery, inform your doctor at least 1 week before the operation. You may need to temporarily stop taking Selincro.
If you feel detached from yourself, see or hear things that are not there, and these experiences last for more than a few days, stop taking Selincro and inform your doctor.
The risk of suicide in people who abuse alcohol and drugs, with or without associated depression, is not reduced by taking nalmefene.
If you are 65 years of age or older, talk to your doctor or pharmacist before taking Selincro.

Children and adolescents
Selincro must not be used in children or adolescents under 18 years of age, as Selincro has not been studied in this age group.

Other medicines and Selincro
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Caution is advised when taking medicines such as diclofenac (an anti-inflammatory medicine used, for example, to treat muscle pain), fluconazole (an antifungal antibiotic used to treat fungal infections), omeprazole (a medicine used to suppress stomach acid production), or rifampicin (an antibiotic used to treat bacterial infections) together with Selincro.
If you take medicines containing opioids, the effects of these medicines may be reduced, or they may not work at all when taken together with Selincro. These medicines include some used for cough and cold, certain medicines for diarrhoea, and strong painkillers.

Selincro with food and alcohol
Selincro does not prevent the intoxicating effects of alcohol.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether Selincro is safe during pregnancy and breastfeeding.
Selincro is not recommended if you are pregnant.
If you are breastfeeding, you and your doctor will need to decide whether to stop breastfeeding or stop treatment with Selincro, taking into account the benefits of breastfeeding for the child and the benefits of therapy for you.

Driving and using machines
At the beginning of treatment with Selincro, side effects such as impaired attention, vision disturbances, abnormal sensations, nausea, dizziness, drowsiness, insomnia, and headache may occur. Most of these reactions were mild or moderate, occurred at the beginning of treatment, and lasted from a few hours to a few days. These side effects may impair your ability to drive or perform tasks requiring attention, including operating machinery.

Selincro contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Selincro

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
How much to take

• The recommended dose is one tablet per day when you anticipate being at risk of drinking alcohol.
• The maximum dose is one tablet per day.

How and when to take it

• Selincro is for oral use.
• Take the tablet 1–2 hours before you start drinking alcohol.
• The tablet must be swallowed whole; do not crush or divide it, as Selincro may cause skin sensitization when in direct contact with the skin.
• You may take Selincro with or without food.
• You can expect to be able to reduce your alcohol consumption within the first month after starting treatment with Selincro.
• Your doctor will monitor you regularly, for example monthly, from the start of treatment with Selincro; the actual frequency will depend on your progress. Together with you, they will decide how to proceed.

If you take more Selincro than you should
If you think you have taken too many Selincro tablets, inform your doctor or pharmacist.
If you forget to take Selincro
If you have started drinking alcohol without taking Selincro, take one tablet as soon as possible.
If you stop taking Selincro
After you have stopped taking Selincro, you may be less sensitive to the effects of opioid-containing medicines for a few days.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A few cases of side effects have been reported, such as seeing, hearing or perceiving things that are not there, or having the feeling of being detached from oneself. However, the frequency of these side effects cannot be estimated from the available data.
The side effects reported with Selincro are mainly mild or moderate, occur at the beginning of treatment, and last from a few hours to several days.
If you continue treatment with Selincro or restart it after a period of interruption, you are unlikely to experience side effects.
In some cases, you may find it difficult to distinguish side effects from symptoms you might experience during reduction of alcohol consumption.
The following side effects have been reported with Selincro:

Very common side effects (may affect more than 1 in 10 people):

• nausea
• dizziness
• inability to sleep
• headache

Common side effects (may affect up to 1 in 10 people):

• loss of appetite
• difficulty sleeping, confusion, feeling restless, reduced sexual interest
• drowsiness, body contractions, feeling less alert, unusual skin sensations such as pins and needles, reduced sensitivity to touch
• rapid heartbeat, sensation of fast, strong or irregular heartbeat
• vomiting, dry mouth, diarrhoea
• excessive sweating
• muscle spasms
• fatigue, weakness, discomfort or malaise, feeling strange
• weight loss

Uncommon side effects (may affect up to 1 in 100 people):

• seeing, hearing or perceiving things that are not there
• feeling detached from oneself

Other side effects (frequency cannot be estimated from the available data):

• visual disturbances (mainly transient)
• swelling of the face, lips, tongue or throat
• hives
• itching
• skin rash
• redness of the skin
• muscle pain
• prolonged erection (priapism)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Selincro

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date (EXP or Exp.) stated on the blister and carton. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice defects such as chips or cracks in the tablets.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Selincro contains

• Each film-coated tablet contains 18.06 mg of nalmefene (as dihydrochloride)
• The other components are: Tablet core: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), magnesium stearate. The tablet coating contains: hypromellose, macrogol 400, titanium dioxide (E171).

Description of the appearance of Selincro and package contents
Selincro is supplied as white, oval, biconvex film-coated tablets, 6.0 x 8.75 mm in size.
The tablets have a 'S' engraved on one side.
Selincro is available in packs of 7, 14, 28, 42, 49 or 98 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
Denmark

Manufacturer
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
Denmark
Elaiapharm
2881, Route des Crêtes
Z.I. Les Bouillides
Sophia Antipolis
06560 Valbonne
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Lundbeck S.A./N.V. H. Lundbeck A/S (Danija)
Tél/Tel: +32 2 535 7979 Tel: + 45 36301311

България Luxembourg/Luxemburg
Lundbeck Export A/S Representative Office Lundbeck S.A.
Teл.: +359 2 962 4696 Tél/Tel: +32 2 535 7979

Česká republika Magyarország
Lundbeck Česká republika s.r.o. Lundbeck Hungária Kft.
Tel: +420 225 275 600 Tel.: +36 1 436 9980

Danmark Malta
Lundbeck Pharma A/S Charles de Giorgio Ltd
Tel: + 45 4371 4270 Tel: +356 25600500

Deutschland Nederland
Lundbeck GmbH Lundbeck B.V.
Tel: +49 40 23649 0 Tel: +31 20 697 1901

Eesti Norge
Lundbeck Eesti AS H. Lundbeck AS
Tel: + 372 605 9350 Tlf: + 47 91 300 800

Ελλάδα Österreich
Lundbeck Hellas S.A. Lundbeck Austria GmbH
Τηλ: + 30 210 610 5036 Tel: +43 1 253 621 6033

España Polska
Lundbeck España S.A. Lundbeck Poland Sp. z o.o.
Tel: +34 93 494 9620 Tel.: + 48 22 626 93 00

France Portugal
Lundbeck SAS Lundbeck Portugal Lda
Tél: + 33 1 79 41 29 00 Tel: +351 21 00 45 900

Hrvatska România
Lundbeck Croatia d.o.o. Lundbeck Romania SRL
Tel: + 385 1 644 826 Tel: +40 21319 88 26

Ireland Slovenija
Lundbeck (Ireland) Ltd Lundbeck Pharma d.o.o.
Tel: +353 1 468 9800 Tel.: +386 2 229 4500

Ísland Slovenská republika
Vistor hf. Lundbeck Slovensko s.r.o.
Sími: +354 535 7000 Tel: +421 2 5341 42 18

Italia Suomi/Finland
Lundbeck Italia S.p.A. Oy H. Lundbeck Ab
Tel: +39 02 677 4171 Puh/Tel: + 358 2 276 5000

Κύπρος Sverige
Lundbeck Hellas A.E H. Lundbeck AB
Τηλ.: + 357 22490305 Tel: +46 60 699 82 00

Latvija United Kingdom (Northern Ireland)
H. Lundbeck A/S (Dānija) Lundbeck (Ireland) Limited
Tel: + 45 36301311 Tel: +353 1 468 9800

Other sources of information
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu